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Positive Cancer Vaccine Data From Moderna And Merck Push mRNA Promise, Stocks Soar

Positive Cancer Vaccine Data From Moderna And Merck Push mRNA Promise, Stocks Soar
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CHICAGO, Dec 13 (Reuters) – An experimental cancer vaccine from Moderna Inc (MRNA.O) based on messenger RNA (MRNA) technology used in successful COVID-19 vaccines has been shown to work against melanoma, which is boosting Moderna shares by more than 20% and other biotechs, working on similar treatments.

A combination of Moderna’s personalized cancer vaccine and that of Merck & Co (MRK.N) Blockbuster immunotherapy Keytruda reduced the risk of recurrence or death from the deadliest skin cancer by 44% compared to Keytruda alone in an intermediate-stage study, the companies said on Tuesday.

The result was considered a “statistically significant and clinically meaningful improvement,” according to the companies.

Shares of Moderna rose nearly 23% to $202.80 on Tuesday, while shares of Merck rose 1%. BioNTech SE shares (22UAy.DE)which also has a successful mRNA vaccine technology, rose 6% and small Gritstone Bio Inc (GRTS.O)which has a cancer vaccine in development, rose 20% to $3.09.

The study is the first randomized trial to show that combining mRNA vaccine technology with a drug that boosts the immune response would offer a better outcome for melanoma patients and potentially other cancers.

“This is a tremendous advance in immunotherapy,” said Eliav Barr, head of global clinical development and Merck’s chief medical officer, in an interview.

Paul Burton, Moderna’s chief medical officer, said in a separate interview that the combination “has the potential to be a new paradigm in the treatment of cancer.”

The ongoing study enrolled 157 patients with stage III/IV melanoma whose tumors had been surgically removed before being treated with either the drug/vaccine combination or Keytruda alone to delay the return of the disease.

The combination was generally safe and showed benefit compared to Keytruda alone after one year of treatment. Serious drug-related side effects occurred in 14.4% of patients receiving the combination, compared with 10% for Keytruda alone.

A PROMISING AREA

In October, Merck exercised an option to co-develop and co-commercialize the treatment, called mRNA-4157/V940, with an equal split of costs and any profits. Merck and Moderna plan to discuss the results with regulatory authorities and start a large phase III study in melanoma patients in 2023.

The collaboration between Merck and Moderna is one of several combinations of potent immune-activating drugs to fight cancer with mRNA vaccine technology. They are designed to attack heavily mutated tumors.

The personalized vaccine works with Merck’s Keytruda, a so-called checkpoint inhibitor designed to disable a protein called programmed death 1, or PD-1, which helps tumors evade the immune system.

To create the vaccine, the researchers took samples of tumors and healthy tissue from the patients. After analyzing the samples to decode their genetic sequence and isolating mutant proteins associated only with cancer, this information was used to design a custom-made cancer vaccine.

When injected into a patient, the patient’s cells act as a manufacturing facility, producing perfect copies of the mutations for the immune system to recognize and destroy.

Moderna’s personalized vaccine can be manufactured in about eight weeks, a timeframe the company eventually hopes to cut in half, Burton said.

Barr said the companies plan to explore the approach in other highly mutated cancers, such as lung cancer. Other such cancers include bladder cancer and some breast cancers.

Modern mRNA rival BioNTech has several cancer vaccine trials in the works, including one with Memorial Sloan Kettering Cancer Center in New York testing a personalized vaccine in combination with Roche’s (ROG.S) Tecentriq in patients with pancreatic cancer.

Gritstone is testing a personalized, self-amplifying mRNA vaccine in combination with Bristol Myers Squibb’s (BMY.N) Immunotherapies Opdivo and Yervoy in a midstage study in patients with advanced solid tumors.

Experts said that after many failures in the field, the personalized vaccines are among several promising cancer vaccine ideas in the works.

“In general, I think cancer vaccines are at a tipping point, and there’s likely to be a lot of vaccines coming into the pipeline over the next five years,” said Dr. Mary Lenora Disis, director of the UW Medicine Cancer Vaccine Institute in Seattle.

Although the COVID-19 pandemic has demonstrated the speed, simplicity, and safety of mRNA vaccines, they are the result of years of cancer vaccine research, Disis said.

Reporting by Julie Steenhuysen in Chicago, Michael Erman in New Jersey and Aditya Samal in Bengaluru; Edited by Caroline Humer, Edwina Gibbs and Bill Berkrot

Our standards: The Thomson Reuters Trust Principles.

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